Lower extremities leg length calculation method

ABSTRACT

A method of calculating leg length discrepancy of a patient including: receiving patient bone data associated with a lower body of the patient; identifying anatomical landmarks in the patient bone data; orienting a first proximal landmark and a second proximal landmark relative to each other and an origin in a coordinate system; aligning a first axis associated with a first femur and a second axis associated with a second femur with a longitudinal axis extending in a distal-proximal direction, wherein the first and second distal landmarks are adjusted according to the alignment of the first and second axes; calculating a distance between the first and second distal landmarks in the distal-proximal direction along the longitudinal axis; and displaying at least one of the distance or a portion of the patient bone data on a display screen.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/743,625, filed Jan. 10, 2018, which was the National Stage ofInternational Application No. PCT/US2016/042129, filed Jul. 13, 2016,which application claims the benefit of U.S. Provisional Application No.62/191,890, filed Jul. 13, 2015. All of the aforementioned applicationsare hereby incorporated by reference in their entireties.

This application incorporates by reference the following applications intheir entireties: U.S. patent application Ser. No. 12/894,071, filedSep. 29, 2010, entitled “SURGICAL SYSTEM FOR POSITIONING PROSTHETICCOMPONENT AND/OR FOR CONSTRAINING MOVEMENT OF SURGICAL TOOL”; U.S.patent application Ser. No. 13/234,190, filed Sep. 16, 2011, entitled“SYSTEMS AND METHOD FOR MEASURING PARAMETERS IN JOINT REPLACEMENTSURGERY”; U.S. patent application Ser. No. 11/357,197, filed Feb. 21,2006, entitled “HAPTIC GUIDANCE SYSTEM AND METHOD”; U.S. patentapplication Ser. No. 12/654,519, filed Dec. 22, 2009, entitled“TRANSMISSION WITH FIRST AND SECOND TRANSMISSION ELEMENTS”; U.S. patentapplication Ser. No. 12/644,964, filed Dec. 22, 2009, entitled “DEVICETHAT CAN BE ASSEMBLED BY COUPLING”; and U.S. patent application Ser. No.11/750,807, filed May 18, 2007, entitled “SYSTEM AND METHOD FORVERIFYING CALIBRATION OF A SURGICAL DEVICE”.

TECHNICAL FIELD

The present disclosure relates generally to surgical methods used inorthopedic joint replacement surgery and, more particularly, to methodsof lower extremities leg length calculations.

BACKGROUND

Robotic systems are often used in applications that require a highdegree of accuracy and/or precision, such as surgical procedures orother complex tasks. Such systems may include various types of robots,such as autonomous, teleoperated, and interactive.

Interactive robotic systems may be preferred for some types of surgery,such as joint replacement surgery, because they enable a surgeon tomaintain direct, hands-on control of the surgical procedure while stillachieving a high degree of accuracy and/or precision. For example, inknee replacement surgery, a surgeon can use an interactive, hapticallyguided robotic arm in a passive manner to sculpt bone to receive a jointimplant, such as a knee implant. To sculpt bone, the surgeon manuallygrasps and manipulates the robotic arm to move a cutting tool (e.g., arotating burr) that is coupled to the robotic arm to cut a pocket in thebone. As long as the surgeon maintains a tip of the burr within apredefined virtual cutting boundary or haptic boundary defined, forexample, by a haptic object, the robotic arm moves freely with lowfriction and low inertia such that the surgeon perceives the robotic armas essentially weightless and can move the robotic arm as desired. Ifthe surgeon attempts to move the tip of the burr to cut outside thevirtual cutting boundary, however, the robotic arm provides hapticfeedback (e.g., forced resistance) that prevents or inhibits the surgeonfrom moving the tip of the burr beyond the virtual cutting boundary. Inthis manner, the robotic arm enables highly accurate, repeatable bonecuts. When the surgeon manually implants a knee implant (e.g., apatellofemoral component) on a corresponding bone cut the implant willgenerally be accurately aligned due to the configuration of andinterface between the cut bone and the knee implant.

The above-described interactive robotic system may also be used in hipreplacement surgery, which may require the use of multiple surgicaltools having different functions (e.g., reaming, impacting), differentconfigurations (e.g., straight, offset), and different weights. A systemdesigned to accommodate a variety of tools is described in U.S. patentapplication Ser. No. 12/894,071, filed Sep. 29, 2010, entitled “SURGICALSYSTEM FOR POSITIONING PROSTHETIC COMPONENT AND/OR FOR CONSTRAININGMOVEMENT OF SURGICAL TOOL”, which is hereby incorporated by reference inits entirety.

During a hip replacement surgery, as well as other robotically assistedor fully autonomous surgical procedures, the patient bone isintra-operatively registered with a corresponding virtual or computerbone model to correlate the pose (i.e., position and rotationalorientation) of the actual, physical bone with the virtual bone model.The patient bone (physical space) is also tracked relative to thesurgical robot, haptic device, or surgical tool with at least one degreeof freedom (e.g., rotating burr). In this way, the virtual cutting orhaptic boundaries controlled and defined on the virtual bone model via acomputer can be applied to the patient bone (physical space) such thatthe haptic device is constrained in its physical movement (e.g.,burring) when working on the patient bone (physical space).

During a hip replacement procedure, a surgeon may attempt to correct apatient's leg length discrepancy (LLD), which is a difference in thelength of the right and left leg, either caused by a true lengthdiscrepancy of one or more bones or a misalignment of one or morejoints. The use of an accurate and reliable algorithm to assess LLDbefore and during surgery is important for planning and executingprecision total hip replacement. Conventional imaging methods formeasuring LLD involve measuring the distance between a pelvic reference(e.g., inter-ischial, tear drop line) and another reference on theproximal or distal femurs. Other conventional methods involve using tapemeasures and standing blocks to assess LLD pre or post-operatively.Intra-operatively, LLD is typically measured manually by palpating thedistal femurs or malleoli with the patient supine and the legs in linewith the shoulders. Most of these methods have limitations and may notprovide reliable measurements of LLD. Thus, there is an opportunity touse pre-operative imaging such as but not limited to computed tomography(CT) data from the pelvis, knees and lower extremities to develop areliable, repeatable algorithm for LLD measurement that accounts for thefull length of the leg.

SUMMARY

Aspects of the present disclosure involve a method of calculating leglength discrepancy of a patient. In certain instances, the method mayinclude receiving patient bone data associated with a lower body of thepatient, the lower body includes a first side and a second side, thefirst side includes a first portion of a pelvis, a first femur, a firsttibia, and a first distal extremity, the second side includes a secondportion of the pelvis, a second femur, a second tibia, and a seconddistal extremity. In certain instances, the method may further includeidentifying anatomical landmarks in the patient bone data, theanatomical landmarks includes a first proximal landmark and a firstdistal landmark associated with the first side and a second proximallandmark and a second distal landmark associated with the second side.In certain instances, the method may further include orienting the firstproximal landmark and the second proximal landmark relative to eachother and an origin in a coordinate system. In certain instances, themethod may further include aligning a first axis associated with thefirst femur and a second axis associated with the second femur with alongitudinal axis extending in a distal-proximal direction, the firstand second distal landmarks may be adjusted according to the alignmentof the first and second axes. In certain instances, the method mayfurther include calculating the leg length discrepancy based on a firstdistance between the first proximal landmark and the first distallandmark and a second distance between the second proximal landmark andthe second distal landmark. In certain instances, the method may furtherinclude displaying at least one of the leg length discrepancy or aportion of the patient bone data on a display screen.

In certain instances, the first axis may include a first femoralmechanical axis, and the second axis may include a second femoralmechanical axis.

In certain instances, the first axis and the second axis may be alignedparallel to the longitudinal axis.

In certain instances, the first and second proximal landmarks remain inan unchanged orientation relative to the origin when the first andsecond axes are aligned relative to the longitudinal axis.

In certain instances, the longitudinal axis may be defined as a normalvector to a pelvic axis extending through the first and second proximallandmarks.

In certain instances, the first proximal landmark may be associated witha first location on the first portion of the pelvis, and the secondproximal landmark may be associated with a second location on the secondportion of the pelvis.

In certain instances, the first tibia and the first distal extremityhave a first alignment relative to the first femur that may be unchangedwhen the first and second axes may be aligned, the second tibia and thesecond distal extremity have a second alignment relative to the secondfemur that may be unchanged when the first and second axes may bealigned.

In certain instances, further includes adjusting at least one of thefirst alignment or the second alignment so as to adjust a condition at aknee joint.

In certain instances, the condition may be a valgus or valrus deformity.

In certain instances, the condition may be a flexed or extended kneejoint.

In certain instances, further includes generating a three dimensionalbone model of the first side and the second side from the patient bonedata.

In certain instances, the patient bone data may include medical imagesof the lower body of the patient.

In certain instances, the medical images were generated from a medicalimaging machine includes at least one of a CT scanner, MRI machine,ultrasound scanner, or X-ray machine.

In certain instances, the patient bone data may be captured via at leastone of an intra-operative bone scanner, a digitizer, or a navigatedultrasound probe.

In certain instances, the first distal extremity may be a first talusbone, and the second distal extremity may be a second talus bone.

In certain instances, calculating the leg length discrepancy may includedetermining a difference between the first and second distances in thedistal-proximal direction.

In certain instances, calculating the leg length discrepancy may includedetermining a distance between the first and second distal landmarks inthe distal-proximal direction.

Aspects of the present disclosure involve a method of calculating leglength discrepancy of a patient body including a first side and a secondside, the first side including a first portion of a pelvis, a firstfemur, a first tibia, and a first foot region, the second side includinga second portion of the pelvis, a second femur, a second tibia, and asecond foot region. In certain instances, the method may includereceiving patient bone data associated with the first and a second sidesof the patient body, one of the first or second sides including adegenerate or deformed condition, the patient bone data having beengenerated by a medical imaging device. In certain instances, the methodmay further include generating a computer model of the first and secondsides of the patient body from the patient bone data. In certaininstances, the method may further include identifying anatomicallandmarks in the patient bone data or the computer model, the anatomicallandmarks includes: a first proximal point and a first distal point onthe first side; and a second proximal point and a second distal point onthe second side. In certain instances, the method may further includeorienting the first and second sides of the computer model relative toeach other in a coordinate system such that: a pelvic axis extendingthrough the first and second proximal points may be generallyperpendicular to a longitudinal axis of the first and second sides ofthe computer model; and a first axis associated with the first femur anda second axis associated with the second femur may be generally parallelto the longitudinal axis. In certain instances, the method may furtherinclude calculating the leg length discrepancy based on the first andsecond sides of the computer model after orienting the first and secondsides of the computer model relative to each other. In certaininstances, the method may further include displaying at least one of theleg length discrepancy or a portion of the computer model on a displayscreen.

In certain instances, the first proximal point corresponds to a femoralhead center of the first femur, and the second proximal pointcorresponds to a femoral head center of the second femur.

In certain instances, the first distal point corresponds to a firstpoint in or on a first bone in the first foot region, and the seconddistal point corresponds to a second point in or on a second bone in thesecond foot region.

In certain instance, further includes: adjusting an orientation of atleast one of a first knee joint of the computer model defined betweenthe first femur and the first tibia or a second knee joint of thecomputer model defined between the second femur and the second tibia.

In certain instances, the patient bone data may include at least one ofCT images, MR images, or X-ray images.

In certain instances, the leg length discrepancy may include determininga distance between the first and second distal points in a direction ofthe longitudinal axis.

In certain instances, the leg length discrepancy may include determininga difference between a first distance and a second distance, the firstdistance defined between the first proximal point and the first distalpoint on the first side, the second distance defined between the secondproximal point and the second distal point on the second side.

Aspects of the present disclosure involve a method of calculating leglength discrepancy of a lower body of a patient includes a pelvicregion, femurs, tibias, and feet. In certain instances, the method mayinclude receiving patient bone data representative of at least a portionof the lower body of the patient including the pelvic region, femurs,tibias, and feet, the patient bone data having been generated via amedical imaging device. In certain instances, the method may furtherinclude generating computer models of the lower body from the patientbone data, the computer models including first and second side pelvicmodels, first and second femur models, first and second tibia models,and first and second foot models. In certain instances, the method mayfurther include orienting the first and second side pelvic modelsrelative to an origin in a coordinate system. In certain instances, themethod may further include orienting the first and second femur models,first and second tibia models, and first and second foot models relativeto the first and second side pelvic models. In certain instances, themethod may further include adjusting an orientation of one of the firstand second femur models, first and second tibia models, or first andsecond foot models with respect to an anteroposterior or mediolateralaxis. In certain instances, the method may further include calculatingthe leg length discrepancy based upon a difference in length between afirst landmark in the first foot model and a second landmark in thesecond foot model in a direction of a longitudinal axis extending fromthe first and second foot models to the first and second side pelvicmodels. In certain instances, the method may further include displayingat least one of the difference or a portion of the computer models on adisplay screen.

In certain instances, the patient bone data may include at least one ofCT images, MR images, or X-ray images.

In certain instances, the first landmark may be a first point in or on atalus bone of the first foot model, and the second landmark may be asecond point in or on a talus bone of the second foot model.

In certain instances, the patient bone data may include informationassociated with a statistical bone model.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a femur and a pelvis.

FIG. 1B is a perspective view of a hip joint formed by the femur andpelvis of FIG. 1A.

FIG. 2A is an exploded perspective view of a femoral component and anacetabular component for a total hip replacement procedure.

FIG. 2B is a perspective view illustrating placement of the femoralcomponent and acetabular component of FIG. 2A in relation to the femurand pelvis of FIG. 1A, respectively.

FIG. 3A is a perspective view of an embodiment of a surgical system.

FIG. 3B is a perspective view of an embodiment of a robotic arm of thesurgical system of FIG. 3A.

FIG. 4 illustrates an embodiment of a computer display for use during asurgical procedure.

FIG. 5A illustrates an embodiment of steps of pre-operatively planning ahip replacement procedure.

FIG. 5B illustrates an embodiment of steps of intra-operativelyperforming a hip replacement procedure.

FIGS. 6 and 7 illustrate an embodiment of a pelvic registration methodshown on a display screen.

FIG. 8 is a flow chart describing a method for measuring leg lengthdiscrepancy pre- and intra-operatively based on lower extremitieslandmarks.

FIG. 9 is a front view of a user interface showing segmentation of thetalus bone.

FIG. 10 is a front view of a user interface showing acquisition of thetalus bone in a CT image.

FIG. 11A is a front view of a user interface showing the alignment ofthe knees in the coronal plane in an un-adjusted manner.

FIG. 11B is a front view of a user interface showing the alignment ofthe knees in the coronal plane in an adjusted manner.

FIG. 11C is another front view of a user interface showing the alignmentof the knees in the coronal plane in an adjusted manner.

FIG. 11D is a front view of a user interface showing the alignment ofthe knees in the coronal and sagittal planes.

FIG. 12A is a coronal view of a skeletal structure of a patient with apelvic tracking array in the pelvis and a femoral tracking array in thefemur prior to the resection of the femur.

FIG. 12B is a coronal view of a skeletal structure of a patient with apelvic tracking array in the pelvis and a femoral tracking array in thefemur following the resection of the femur and implantation of a femoraland acetabular component of a hip replacement system.

FIG. 12C is a coronal view of a skeletal structure of a patient with apelvic tracking array in the pelvis and distal extremity points probedvia a localizer device prior to resection of the femur.

FIG. 12D is a coronal view of a skeletal structure of a patient with apelvic tracking array in the pelvis and distal extremity points probedvia a localizer device following the resection of the femur andimplantation of a femoral and acetabular component of a hip replacementsystem.

FIG. 13 is an example computing system having one or more computingunits that may implement various systems and methods discussed herein isprovided.

DETAILED DESCRIPTION

I. Overview

The hip joint is the joint between the femur and the pelvis andprimarily functions to support the weight of the body in static (e.g.,standing) and dynamic (e.g., walking) postures. FIG. 1A illustrates thebones of a hip joint 10, which include a left pelvis 12 and a proximalend of a left femur 14. The proximal end of the femur 14 includes afemoral head 16 disposed on a femoral neck 18. The femoral neck 18connects the femoral head 16 to a femoral shaft 20.

As shown in FIG. 1B, the femoral head 16 fits into a concave socket inthe pelvis 12 called the acetabulum 22, thereby forming the hip joint10. The acetabulum 22 and femoral head 16 are both covered by articularcartilage that absorbs shock and promotes articulation of the joint 10.Over time, the hip joint 10 may degenerate (e.g., due to osteoarthritis)resulting in pain and diminished functionality. As a result, a hipreplacement procedure, such as total hip arthroplasty or hipresurfacing, may be necessary. During hip replacement, a surgeonreplaces portions of a patient's hip joint 10 with artificialcomponents. In total hip arthroplasty, the surgeon removes the femoralhead 16 and neck 18 and replaces the natural bone with a prostheticfemoral component 26 comprising a head 26 a, a neck 26 b, and a stem 26c (shown in FIG. 2A). As shown in FIG. 2B, the stem 26 c of the femoralcomponent 26 is anchored in a cavity the surgeon creates in theintramedullary canal of the femur 14. Alternatively, if disease isconfined to the surface of the femoral head 16, the surgeon may opt fora less invasive approach in which the femoral head is resurfaced (e.g.,using a cylindrical reamer) and then mated with a prosthetic femoralhead cup (not shown). Similarly, if the natural acetabulum 22 of thepelvis 12 is worn or diseased, the surgeon resurfaces the acetabulum 22using a reamer and replaces the natural surface with a prostheticacetabular component 28 comprising a hemispherical shaped cup 28 a(shown in FIG. 2A) that may include a liner 28 b. To install theacetabular component 28, the surgeon connects the cup 28 a to a distalend of an impactor tool and implants the cup 28 a into the reamedacetabulum 22 by repeatedly striking a proximal end of the impactor toolwith a mallet. If the acetabular component 28 includes a liner 28 b, thesurgeon snaps the liner 28 b into the cup 28 a after implanting the cup28 a. Depending on the position in which the surgeon places the patientfor surgery, the surgeon may use a straight or offset reamer to ream theacetabulum 22 and a straight or offset impactor to implant theacetabular cup 28 a. For example, a surgeon that uses a postero-lateralapproach may prefer straight reaming and impaction whereas a surgeonthat uses an antero-lateral approach may prefer offset reaming andimpaction.

II. Exemplary Robotic System

A surgical system described herein may be utilized to perform hipreplacement, as well as other surgical procedures. As shown in FIG. 3A,an embodiment of a surgical system 5 for surgical applications accordingto the present disclosure includes a computer assisted navigation system7, a tracking device 8, a computer 15, a display device 9 (or multipledisplay devices 9), and a robotic arm 30.

The robotic arm 30 can be used in an interactive manner by a surgeon toperform a surgical procedure on a patient, such as a hip replacementprocedure. As shown in FIG. 3B, the robotic arm 30 includes a base 32,an articulated arm 34, a force system (not shown), and a controller (notshown). A surgical tool 58 (e.g., a rotary burring device as seen inFIG. 3A, an end effector 40 having an operating member as seen in FIG.3B) is coupled to an end of the articulated arm 34, and the surgeonmanipulates the surgical tool 58 by grasping and manually moving thearticulated arm 34 and/or the surgical tool.

The force system and controller are configured to provide control orguidance to the surgeon during manipulation of the surgical tool. Theforce system is configured to provide at least some force to thesurgical tool via the articulated arm 34, and the controller isprogrammed to generate control signals for controlling the force system.In one embodiment, the force system includes actuators and abackdriveable transmission that provide haptic (or force) feedback toconstrain or inhibit the surgeon from manually moving the surgical toolbeyond predefined virtual boundaries defined by haptic objects asdescribed, for example, in U.S. patent application Ser. No. 11/357,197(Pub. No. US 2006/0142657), filed Feb. 21, 2006, and/or U.S. patentapplication Ser. No. 12/654,519, filed Dec. 22, 2009, each of which ishereby incorporated by reference herein in its entirety. In a certainembodiment the surgical system is the RIO® Robotic Arm InteractiveOrthopedic System manufactured by MAKO Surgical Corp. of FortLauderdale, Fla. The force system and controller are preferably housedwithin the robotic arm 30.

The tracking device 8 is configured to track the relative locations ofthe surgical tool 58 (coupled to the robotic arm 30) and the patient'sanatomy. The surgical tool 58 can be tracked directly by the trackingdevice 8. Alternatively, the pose of the surgical tool can be determinedby tracking the location of the base 32 of the robotic arm 30 andcalculating the pose of the surgical tool 58 based on joint encoder datafrom joints of the robotic arm 30 and a known geometric relationshipbetween the surgical tool and the robotic arm 30. In particular, thetracking device 8 (e.g., an optical, mechanical, electromagnetic, orother known tracking system) tracks (or enables determination of) thepose (i.e., position and orientation) of the surgical tool and thepatient's anatomy so the navigation system 7 knows the relativerelationship between the tool and the anatomy.

In operation, a user (e.g., a surgeon) manually moves the robotic arm 30to manipulate the surgical tool 58 (e.g., the rotary burring device, theend effector 40 having an operating member) to perform a surgical taskon the patient, such as bone cutting or implant installation. As thesurgeon manipulates the tool 58, the tracking device 8 tracks thelocation of the surgical tool and the robotic arm 30 provides haptic (orforce) feedback to limit the surgeon's ability to move the tool 58beyond a predefined virtual boundary that is registered (or mapped) tothe patient's anatomy, which results in highly accurate and repeatablebone cuts and/or implant placement. The robotic arm 30 operates in apassive manner and provides haptic feedback when the surgeon attempts tomove the surgical tool 58 beyond the virtual boundary. The hapticfeedback is generated by one or more actuators (e.g., motors) in therobotic arm 30 and transmitted to the surgeon via a flexibletransmission, such as a cable drive transmission. When the robotic arm30 is not providing haptic feedback, the robotic arm 30 is freelymoveable by the surgeon and preferably includes a virtual brake that canbe activated as desired by the surgeon. During the surgical procedure,the navigation system 7 displays images related to the surgicalprocedure on one or both of the display devices 9.

To aid in tracking the various pieces of equipment within the system,the robotic arm 30 may include a device marker 48 to track a global orgross position of the robotic arm 30, a tool end marker 54 to track thedistal end of the articulating arm 34, and a free-hand navigation probe56 for use in the registration process. Each of these markers 48, 54, 56(among others such as navigation markers positioned in the patient'sbone) is trackable by the tracking device 8 with optical cameras, forexample.

The computer 15 may include a display and an input device (e.g.,keyboard, mouse) and is configured to communicate with the navigationsystem 7, the tracking device 8, the various display devices 9 in thesystem, and the robotic arm 30. Furthermore, the computer 15 may receiveinformation related to a particular surgical procedure and performvarious functions related to performance of the surgical procedure. Forexample, the computer 15 may have software as necessary to performfunctions related to image analysis, surgical planning, registration,navigation, image guidance, and haptic guidance. A more detailedanalysis of an example computing system having one or more computingunits that may implement various systems and methods discussed herein,is described subsequently in reference to FIG. 14.

FIG. 3B depicts an end effector 40 particularly suited for use inrobotic assisted hip arthroplasty. The end effector 40 is configured tobe mounted to an end of the robotic arm 30. The end effector 40 includesa mounting portion 50, a housing, a coupling device, and a releasemember. The end effector 40 is configured to individually andinterchangeably support and accurately position multiple operatingmembers relative to the robotic arm 30. As seen in FIG. 3B, the endeffector 40 is coupled to an operating member 100. The end effector 40and related tools, systems, and methods are described in U.S. patentapplication Ser. No. 12/894,071, filed Sep. 29, 2010, which is herebyincorporated by reference in its entirety.

The mounting portion (or mount) 50 preferably couples the end effector40 to the robotic arm 30. In particular, the mounting portion 50 extendsfrom the housing and is configured to couple the end effector 40 to acorresponding mounting portion 35 of the robotic arm 30 using, forexample, mechanical fasteners, such that the mounting portions are fixedrelative to one another. The mounting portion 50 can be attached to thehousing or formed integrally with the housing and is configured toaccurately and repeatably position the end effector 40 relative to therobotic arm 30. In one embodiment, the mounting portion 50 is asemi-kinematic mount as described in U.S. patent application Ser. No.12/644,964, filed Dec. 22, 2009, and hereby incorporated by referenceherein in its entirety.

The end effector 40 in FIG. 3B is one example of a surgical tool thatcan be tracked and used by the surgical robotic arm 30. Other tools(e.g., drills, burrs) as known in the art can be attached to the roboticarm for a given surgical procedure.

III. Pre-operative Planning a Surgical Procedure

Referring to FIGS. 4 and 5A, a preoperative CT (computed tomography)scan of the patient's pelvis 12 and femur 14 is generated or obtained atstep R1. The scan image may be generally described as “patient data” or“patient bone data.” Such patient data may be generated with a medicalimaging device (e.g., CT scanner) prior to the surgical procedure. Whilethe discussion will focus on CT scans, other imaging modalities (e.g.,MRI) may be similarly be employed. Additionally and alternatively, X-rayimages derived from the CT scan and/or the three dimensional models 512,514 can be used for surgical planning, which may be helpful to surgeonswho are accustomed to planning implant placement using actual X-rayimages as opposed to CT based models. The CT scan may be performed bythe surgeon or at an independent imaging facility. Additionally oralternatively, intra-operative imaging methods may be employed togenerate a patient model of the bone. For example, various boneysurfaces of interest may be probed with a tracked probe to generate asurface profile of the surface of interest. The surface profile may beused as the patient bone model. Additionally and alternatively, genericbone data or models (e.g., based on statistical averages of a samplepopulation) that are at least partially representative of the patient'sbone shape and lengths, among other characteristics, may be used inplace of or in addition to patient data that is sampled from the actualpatient bone. In such an instance, a representative bone data set ormodel may be selected or generated that approximates the lengths andconditions of the actual patient bone. Accordingly, the presentdisclosure is applicable to all methods of obtaining or generatingpatient bone data and a patient bone model or a portion thereof.

As shown in FIG. 4 and at step R2 of FIG. 5A, the CT scan or data fromthe CT scan is segmented and to obtain a three dimensional model 512 ofthe pelvis 12 and a three dimensional model 514 of the femur 14. At stepR3, leg length discrepancy (LLD) is determined prior to the surgery.Determining LLD pre-operatively is described more fully in thesubsequent paragraphs.

At steps R4 and R5 of FIG. 5A, the three dimensional models 512, 514 areused by the surgeon to construct a surgical plan at least in part tocorrect LLD. The surgeon selects an implant at step R4 of FIG. 5A andselects a desired pose (i.e., position and orientation) of theacetabular component and the femoral component relative to the models512, 514 of the patient's anatomy. For example and as seen in FIG. 4, aplanned pose 500 of the acetabular cup can be designated and displayedon a computer display, such as the display device 9. At step R5 of FIG.5A, the various bone cuts or resections may be determined based upon thedesired pose of the implant, among other possible factors.

It is noted that the pre-operatively planning may include a plan for aknee arthroplasty procedure in addition to a hip arthroplasty procedure.The knee arthroplasty procedure may be at the same time as the hipprocedure or at a later time. Either way, correction of the LLD, amongother deformities, may be in part due to the hip arthroplasty procedureand in part from the knee arthroplasty procedure. For example, thepre-operative planning may include a present correction of a shorterfemur in a hip arthroplasty procedure while also planning for aneventual correction to a varus/valgus knee deformity in a kneearthroplasty occurring subsequent to the hip arthroplasty procedure.

A. Leg Length Calculation

In certain instances, LLD may be pre-operatively determined and thencompared with an intra-operative determination of LLD, which will bediscussed in subsequent sections of this application. In certaininstances, step R3 of determining pre-operative LLD may be based onusing anatomical information between the proximal femurs and the lowerextremities. Through imaging of the pelvis, knees, ankles and feet, themethod of determining LLD described herein can be used to acquireinformation on the mechanical axes and use a distal landmark such as,for example, the calcaneus or talus, among other landmarks, to calculateLLD using the full length of the legs. While conventional (manualsurgical) methods typically rely on subjective visual assessments of theknee positions, and conventional computer-assisted surgical methodsfocus only on “hip length” at the level of the greater or lessertrochanter or above, the method described herein utilizes computerassisted surgical systems and provides an LLD measurement that accountsfor the full length of the legs.

Referring back to step R1 of FIG. 5A and to step T1 of FIG. 8, whichdepicts a flow diagram of a method of calculating and correcting LLD,patient bone data or medical images of the pelvis, proximal femur, knee,ankle, and foot may be pre-operatively generated or obtained for boththe affected and non-affected legs. As stated previously, variousimaging modalities may be utilized to generate the patient bone datasuch as, for example, CT, MRI, X-ray, or the like. The patient bone datamay provide various anatomical landmarks for calculating LLD pre- andintra-operatively.

As shown in step R2 of FIG. 5A and step T2 of FIG. 8, athree-dimensional patient bone model is generated from the patient bonedata via a segmentation process or otherwise. In certain instances, asegmentation process may include outlining or segmenting a boundary of aparticular bone on each of a plurality of image scans or slices in acertain plane (e.g., sagittal, transverse, coronal). The segmenting ofthe image scans provides an outline of points on the bone at discreteincrements. The plurality of image scans may be positioned adjacent toeach other such that there is a gap between each image scan that isequal to the scan spacing (e.g., 2 mm) of the imaging machine.Generating the bone model entails extrapolating a surface in the gaparea between the adjacent image slices so as to make a solid or surfacemodel from the plurality of spaced-apart and segmented image scans.While a segmentation process is described herein, any known method ofgenerating the bone models may be used for the purposes of thisdiscussion.

At step T3 of FIG. 8, landmarks are selected in either the medicalimages or the three dimensional patient bone models. More particularly,the following anatomical landmarks may be selected or identified foreach leg: anterior-superior iliac spine (ASIS), femoral head center,knee center, talus centroid. The list of landmarks is not exhaustive andmay include additional or different landmarks without departing from thescope of the present disclosure.

An illustrative example of identifying and selecting the talus centroidcan be seen in FIGS. 9 and 10. As seen in FIG. 9, which is a displayscreen 9 illustrating patient bone data 600 in the form of twodimensional images of a patient's foot 602 in various planes, the talusbone 604 is segmented in the top-right image along a bone boundary line606 that separates the bone 604 from the surrounding tissue 608. A usermay segment the individual slices of the talus bone 604, for example, inthis view. The views of the talus bone 604 on the top-left, bottom-left,and bottom-right illustrate coronal, transverse, and sagittal views,respectively, and each view illustrates a user selecting a center point610 of the talus bone 604 with cross-hairs movable via a cursor, forexample. Since the talus bone 604 is three-dimensional in physicalspace, the centroid or center of mass 612, as seen in FIG. 10, may bedetermined by identifying the center point 610 in the coronal,transverse, and sagittal views of the two dimensional images 602, asshown in FIG. 9.

Upon completing the segmentation process for the talus bone 604 as shownin FIG. 9, the system 5 may generate the three dimensional bone model614 of the talus bone 604, as well as other segmented bones of the foot,as seen in the top-right of FIG. 10. As seen in the top-left,bottom-right, and bottom-left views of FIG. 10, the illustrations arethe same as those shown in FIG. 9. Locational information pertaining tothe position of the centroid 612 may be stored within the threedimensional bone model 614.

In certain instances, calculating LLD may be done without generatingthree dimensional bone models of the various bones described herein.That is, the anatomical landmarks may be identified in the image data(e.g., CT, MRI, X-ray), and coordinates (e.g., x, y, z) associated withthe identified landmarks may be used for calculating LLD withoutgenerating a 3D surface model of the bones.

And while the talus bone 604 is referenced herein as a distal or lowerextremity landmark, other bones at or near the foot (e.g., navicular,calcaneus) or other landmarks of the talus (e.g., most distal aspect ofthe talus) may be used for purposes of calculating LLD without departingfrom the teachings of the present disclosure.

While segmentation and identification of landmarks is only shown for thetalus bone 604, segmentation and three dimensional bone model generationmay continue for the each of the two dimensional images of the pelvis12, femur 14, and tibia 13, as described in any of the applicationsincorporated by reference. In certain embodiments, the anatomicallandmarks may be selected or identified in the two dimensional medicalimages or the three dimensional bone model for the femur head centersand knee centers, as shown at step T3 of FIG. 8, in a similar manner asdescribed with reference to the talus bone 604 in FIGS. 9 and 10.

At step T4 of FIG. 8, the three dimensional bone models of the femur,tibia, and talus 514, 513, 614, together referred to as a patient bonemodel in an unadjusted state 650 and an adjusted state 652, aredisplayed on a display screen 9 and the femoral models 514 of thepatient bone models 650, 652 are aligned relative to a longitudinal orvertical axis VA of the pelvis, as seen in FIG. 11A. In certaininstances, as seen in FIG. 11D, the three dimensional bone model of thepelvis 624 may be used in the calculation and may be used to define apelvic axis PA, for example, as extending medial-lateral across oppositepoints on the pelvis. The pelvic axis PA may be used to define thelongitudinal or vertical axis VA of the pelvis as being a normal vectorof the pelvic axis PA.

In certain instances, the femoral head centers 616 of the right and leftfemurs of the patient bone models 650, 652 may be parallel to the pelvicaxis PA (extending in a medial-lateral direction). In this case, theproximal femurs of the right and left legs are fixed relative to eachother such that LLD may be determined at a distal anatomical landmarksuch as the talus bone, which provides an LLD calculation thatencompasses the entire lengths of the legs.

In certain instances, the femoral models 514 may be aligned relative tothe vertical axis VA, but not otherwise fixed or “zeroed” relative toeach other at the pelvic axis PA (i.e., the right and left femoral headcenters may be at different elevations on along the vertical axis VA).While right and left proximal femurs whose femoral head centers 616 areparallel with the pelvic axis PA allows for a length measurement to bedetermined only by the difference at the distal extremities (as noted bythe distance D1 in FIGS. 11B and 11C), the distance D1 may also be foundby measuring the entire length of each leg from a proximal landmark(e.g., ASIS, tear-drop, inferior ischial, femoral head center) to adistal landmark (e.g., talus centroid, distal aspect of talus or tibia),and determining the difference in length D1 between the right and leftlegs. In this way, the proximal landmarks may be at different elevationson the vertical axis VA (i.e., not parallel to the pelvic axis) and ameasure of LLD may be found. While the disclosure includes reference toa determination of leg length between the distal landmarks of a rightand left leg, other measurements may be used, such as those described inthis paragraph and others, to measure the difference in leg lengthbetween the right and left legs.

In certain instances and as seen in FIG. 11D, the pelvic model 624 maybe used to define the coordinate system of the pelvic axis PA and thelongitudinal or vertical axis VA, and the other bone models (e.g.,femur, tibia, talus) may be oriented relative to the pelvic model 624.In such instances, the pelvic axis PA may be defined by identifying andselecting opposite points on the pelvic model 624 and defining an axisthrough the points. For example and as shown in FIG. 11D, the ASIS 625may be selected (at step T3 of FIG. 8) on a right and left side of thepelvic model 624, and a line (the pelvic axis PA) may extend through theright and left ASIS 625. Once the pelvic axis PA is defined from thepelvic model 624, the longitudinal or vertical axis VA may be defined asa normal vector of the pelvic axis PA.

Once the vertical axis VA is defined, the femoral mechanical axes FMA ofthe femur models 514 may be aligned with the vertical axis VA of thepelvis, at step T4 of FIG. 8. It is noted, the femur and pelvic models514, 624 may be joined together such that aligning of the pelvic model624 with the pelvic axis PA may cause the femur models 514 to moveaccordingly within the coordinate system. For example, the center of theacetabulum may be used as a common point between the pelvic and femurmodels 624, 514 to join the models relative to each other, whileallowing the femur model 514 to rotate about the center of acetabulum.In this way, once the pelvic model 624 is aligned relative to the pelvicaxis PA, the femur model 514 is free to rotate about the center ofacetabulum, but is restricted from translating within the coordinatesystem.

Aligning the pelvic model 624 in the medial-lateral direction via theselected points on, for example, the ASIS and defining the pelvic axisPA in this way allows for consideration of cartilage degeneration, andother factors, at the hip joint that may cause a perceived discrepancyin leg length even if the length of the right and left legs are thesame. For example, a right hip joint of a patient may be normal with ahealthy amount of cartilage at the joint and a left hip joint may bediseased with very little cartilage present in the joint. The patientmay perceive a shorter left leg because of the difference in cartilageat the left hip joint despite the right and left legs being the samelength. In such an instance, if femoral points were used to define thepelvic axis PA, as opposed to points on the pelvic model 624, the rightand left legs may measure as equal when, in this example, there isdegeneration at the joint that causes a perception of leg lengthdiscrepancy.

Referring back to FIGS. 11A-11C, while the pelvic model 624 is notdisplayed, the femoral head centers 616 are shown relative to a pelvicaxis PA that may be defined based on selected points (e.g., ASIS) on thepelvic model 624. As seen in FIG. 11A, other deformities, such as thoseat the knee (e.g., varus/valgus deformities), may remain unadjusted atthis point. Adjustment of the knee deformities, for example via a kneearthroplasty and its effect on LLD, will be addressed subsequently.

Upon defining the pelvic axis PA and longitudinal or vertical axis VA,described previously, the mechanical axes of the femur models 514 of theaffected (right side) and unaffected side (left side) are aligned to beparallel with the vertical axis VA, as described in step T4 of FIG. 8and as seen in FIGS. 11A and 11B. Adjustment of the femoral and tibialmechanical axes can be seen in FIG. 11B, which illustrates a displayscreen 9 showing an adjusted bone model 652, with adjustments made atthe hip and knee region. The bone models 650, 652 both include thefemur, tibia, and talus bone models 514, 513, 614 and the identifiedfemoral head centers 616, knee centers 618, and talus centroids 612. Thefemoral mechanical axis FMA is defined between the femoral head center616 and the knee center 618. The tibial mechanical axis TMA is definedbetween the knee center 618 and the talus centroid 612.

As seen in FIG. 11A, the un-adjusted bone model 650 represents a valgusknee 620 on the right and a normal knee 622 on the left. The mechanicalaxes FMA, TMA of the valgus knee 620 are offset and non-parallel to eachother and to the vertical axis VA, whereas the mechanical axes FMA, TMAof the normal knee 622 are generally parallel to each other and thevertical axis VA. Upon aligning the femoral mechanical axes FMA with thevertical axis, the bone model 652 will appear as shown in FIG. 11B(which also shows a correction of the valgus knee joint).

In certain instances, the system 5 may use the identified anatomicallandmarks as end points associated with the femoral and tibialmechanical axes FMA, TMA, and the system 5 may display the bone modelsof the femur, tibia, and talus bones 514, 513, 614 in the sameorientation as the patient was positioned during an image scan (e.g.,CT). In certain instances, an adjustment of the right and left femurmodels may cause the tibia and talus models to move accordingly whilemaintaining their original orientation relative to the femur models. Inthis way, a knee deformity may not be corrected by the initialadjustment of the right and left femur models to be parallel to thevertical axis. In certain instances, the system or surgeon may corrector adjust the orientation of the tibia and talus models relative to thefemur so as to correct or adjust a knee or ankle deformity.

At steps T5 and T6 of FIG. 8, the femoral and tibial mechanical axesFMA, TMA, among other parameters including varus/valgus deformities,flexion/extension angles of the knee, among others, can be identified,and adjusted or fixed by the system 5 and displayed on the displayscreen 9.

The surgeon may view the bone model 650 in FIG. 11A in various views tocalculate knee deformities, as seen in step T5 of FIG. 8. For example,varus/valgus deformities may be seen in a coronal view, as depicted inFIG. 11A, whereas flexion/extension angles may be seen in a sagittalview (not shown).

At step T6 and as seen in FIG. 11B, the system 5 may allow a user (e.g.,surgeon) to set values for the femoral and tibial mechanical axes FMA,TMA relative to each other or the vertical axis VA to correctvarus/valgus deformities, flexion/extension of the knee, and otherparameters, such that the three dimensional bone models of the femur,tibia, and talus 514, 513, 614 will be moved according to the inputtedvalues. In this way, the surgeon may virtually align both the affected(right side in FIG. 11A) and non-affected (left side in FIG. 11A) sidesof the patient's body in a similar manner (e.g., with both affected andnon-affected sides having zero degrees mechanical axis) so LLD may bepre-operatively determined or calculated, regardless of the orientationof the patient's body during the acquisition of two dimensional images.

Thus, as seen in FIG. 11B, the system 5 has adjusted the formerly valgusknee 620 by aligning the femoral and tibial mechanical axes FMA, TMA tobe generally parallel with each other and the vertical axis VA. In thisway, both knees 620, 622 match each other with regard to femoral andtibial mechanical axes FMA, TMA. Adjustment of the valgus knee may be inanticipation of a knee arthroplasty procedure at the same time as thehip procedure or at another time as part of an effort to correct LLD atthe hip and knee.

In certain instances, as seen in FIG. 11C, which is a coronal view of anadjusted bone model 652 displayed on a display screen 9, a surgeon maynot adjust the valgus knee on the right, but, upon adjusting themechanical axis FMA of the femur model 514 to be parallel with thevertical axis VA, the surgeon may leave the orientation of the femurrelative to the tibia unadjusted.

In certain instances, as seen in step T7 of FIG. 8, the system 5 maypre-operatively calculate LLD as the distance D1 between the taluscentroids 612 as measured relative to the vertical axis VA. Moreparticularly and as seen in FIGS. 11B and 11C, LLD may be measured asthe distance D1, along the vertical axis VA, between a firstperpendicular line P1 intersecting a first talus centroid 612 and asecond perpendicular line P2 intersecting a second talus centroid 612.As discussed previously, the distance D1 may be calculated by measuringthe length of the entire right and left legs and calculating thedifference. For example, each of the right and left legs may be measuredfrom the pelvic axis (e.g., right and left ASIS) to the talus centroid612, and the difference between the right and left legs will yield thedistance D1.

In this way, an LLD calculation is made by virtually aligning the bonemodels 650, 652 that will be representative of the patient's physicalbody following a hip and/or a knee arthroplasty procedure. Using adistal anatomical landmark such as the talus bone provides an LLDcalculation that encompasses the entire lengths of the legs as opposedto conventional methods, which focus on only the proximal femur. And byincluding information from the pelvis, such as using the pelvic axis PAas defined through points (e.g., ASIS) on the pelvis, allows for an LLDcalculation that captures potential degeneration at the joint as well asother deformities of the leg(s).

It is also noted that while the embodiment in FIGS. 11A-11C do not showthe pelvic model 624, in certain instances, as seen in FIG. 11D, a threedimensional bone model 624 of the pelvis 12 may be depicted on thedisplay screen 9 along with the bone models of the femur, tibia, andtalus 514, 513, 614. As seen in FIG. 11D, which is a front view of adisplay screen 9 showing the bone models 514, 513, 614, a surgeon mayset values for varus deformities 626 and extension 628 at the knee. Uponsetting the values, the hip length or LLD is displayed 630 accordingly.In the embodiment in FIG. 11D, the un-adjusted bone model 650 andadjusted bone model 652 may be combined to show only a single bone model650, 652 that is adjusted according to the set values or not adjusted ifthe values are unmodified.

At step T9 of FIG. 8, the surgeon pre-operatively plans the hipreplacement procedure to correct the LLD as determined from step T7.During this step, the surgeon may select an implant and determine theposition and orientation of the implant to correct the LLD, as seen instep R4 of FIG. 5A. Selection of the implant and determination of thepose of the implant may influence the determination of the bone cuts orresections to perform on the bones (e.g., proximal femur, acetabulum),as seen in step R5 of FIG. 5A. For example, implant stem length may be afactor to consider to lengthen or shorten the length of the femur tocompensate for a particular LLD deformity.

It is noted that in certain instances, patient data may be captured viaa localizer tool (e.g., digitizer, navigated ultrasound probe) by asurgeon just prior to or during the surgical procedure. In suchinstances, the patient data obtained from the localizer tool may takethe place of obtaining pre-operative images (e.g., CT, Mill, X-ray) atstep T1, of FIG. 8, and generating a 3D bone model at step T2, also ofFIG. 8. The localizer tool may gather information about a particularbone such as surface contour information, rotational information (e.g.,center of rotation), or location data associated with certain anatomicallandmarks. The gathered information may be used by the system 5 tocalculate mechanical axes (e.g., FMA, TMA) and develop a model withwhich to calculate and adjust deformities, at step T5 and T6 of FIG. 8.

The remaining portions of the intra-operative procedure will bediscussed in the following sections.

IV. Intra-Operative Procedures

During the surgical procedure and referring back to FIG. 3A, motion ofthe patient's anatomy and the surgical tool in physical space aretracked by the tracking device 8, and these tracked objects areregistered to corresponding models in the navigation system 7 (imagespace). As a result, objects in physical space are correlated tocorresponding models in image space. Therefore, the surgical system 5knows the actual position of the surgical tool relative to the patient'sanatomy and the planned pose 500 (as seen in FIG. 4), and thisinformation is graphically displayed on the display device 9 during thesurgical procedure.

A. Tracking and Registration of Femur

FIG. 5B illustrates an embodiment of intra-operative steps of performinga total hip replacement. In this embodiment, steps S1-S12 may beperformed with or without the robotic arm 30. For example, step S8(reaming) can be performed using robotic arm 30 with the end effector 40coupled to the operating member 100 or the operating member 200, andstep S10 (impacting) can be performed using the robotic arm 30 with theend effector 40 coupled to the operating member 300 or the operatingmember 400.

In step S1 of the surgical procedure, as seen in FIG. 12A, which is acoronal view of a patient's skeletal structure to undergo a hiparthroplasty procedure, a cortical tracking array 632 is attached to thefemur 14 to enable the tracking device 8 to track motion of the femur14. In step S2, the femur 14 is registered (using any known registrationtechnique) to correlate the pose of the femur 14 (physical space) withthe three dimensional model 514 of the femur 14 in the navigation system7 (image space). Additionally, the femur checkpoint is attached. In stepS3, the femur 14 is prepared to receive a femoral implant (e.g., thefemoral component 26) using a navigated femoral broach.

B. Tracking and Registration of Pelvis

In step S4 of FIG. 5B, a pelvic tracking array 634 is attached to thepelvis 12 to enable the tracking device 8 to track motion of the pelvis12, as seen in FIG. 12A. In step S5, a checkpoint is attached to thepelvis 12 for use during the surgical procedure to verify that thepelvic tracking array has not moved in relation to the pelvis 12. Thecheckpoint can be, for example, a checkpoint as described in U.S. patentapplication Ser. No. 11/750,807 (Pub. No. US 2008/0004633), filed May18, 2007, and hereby incorporated by reference herein in its entirety.

In step S6, the pelvis 12 is registered to correlate the pose of thepelvis 12 (physical space) with the three dimensional model 512 of thepelvis 12 in the navigation system 7 (image space). In certainembodiments, as shown in FIG. 6, registration is accomplished using thetracked navigation probe 56 to collect points on the pelvis 12 (physicalspace) that are then matched to corresponding points on the threedimensional model 512 of the pelvis 12 (image space). Two methods ofregistering the three dimensional model 512 of the pelvis (image space)and the pelvis 12 (physical space) are described in the subsequentsections of this application.

As shown in FIG. 6, the display device 9 may show the representation 512of the pelvis 12, including one or more registration points 516. Theregistration points 516 help the surgeon understand where on the actualanatomy to collect points with the tracked probe. The registrationpoints 516 can be color coded to further aid the surgeon. For example, aregistration point 516 on the pelvis 12 to be collected next with thetracked probe can be colored yellow, while registration points 516 thathave already been collected can be colored green and registration points516 that will be subsequently collected can be colored red. Afterregistration, the display device 9 can show the surgeon how well theregistration algorithm fit the physically collected points to therepresentation 512 of the pelvis 12.

For example, as shown in FIG. 7, error points 518 can be displayed toillustrate how much error exists in the registration between the surfaceof the representation 512 and the corresponding surface of the physicalpelvis 12. In one embodiment, the error points 518 can be color coded,for example, with error points 518 representing minimal error displayedin green and error points 518 representing increasing amounts of errordisplayed in blue, yellow, and red. As an alternative to color coding,error points 518 representing different degrees of error could havedifferent shapes or sizes. Verification points 519 can also bedisplayed. The verification points 519 illustrate to the surgeon whereto collect points with the tracked probe to verify the registration.When a registration point 519 is collected, the software of thenavigation system 7 displays the error (e.g., numerically inmillimeters) between the actual point collected on the anatomy and theregistered location of the representation 512 in physical space. If theregistration error is too high, the surgeon re-registers the pelvis 12by repeating the registration process of step S6.

C. Registering of Robotic Arm

Referring back to FIG. 5B, after registering the pelvis at step S6, therobotic arm 30 may be registered at step S7. In this step, the roboticarm 30 is registered to correlate the pose of the robotic arm 30(physical space) with the navigation system 7 (image space). The roboticarm 30 can be registered, for example, as described in U.S. patentapplication Ser. No. 11/357,197 (Pub. No. US 2006/0142657), filed Feb.21, 2006, and hereby incorporated by reference herein in its entirety.

D. Preparation of the Acetabulum and Performance of the SurgicalProcedure

In operation, the surgeon can use the robotic arm 30 to facilitate ajoint replacement procedure, such as reaming bone and implanting anacetabular cup for a total hip replacement or hip resurfacing procedure.As explained above, the robotic arm 30 includes a surgical toolconfigured to be coupled to a cutting element (for reaming) and toengage a prosthetic component (for impacting). For example, for reaming,the end effector 40 can couple to the operating member 100 or theoperating member, each of which couples to the cutting element.Similarly, for impacting, the end effector 40 can couple to theoperating member or the operating member, each of which engages theprosthetic component. The robotic arm 30 can be used to ensure properpositioning during reaming and impacting.

In step S8 of FIG. 5B, the surgeon resurfaces the acetabulum 22 using areamer, such as the operating member 100, coupled to the robotic arm 30.As described above in connection with the operating member 100, thesurgeon couples the appropriate operating member (e.g., a straight oroffset reamer) to the end effector 40, connects the cutting element tothe received operating member, and manually manipulates the robotic arm30 to ream the acetabulum 22. During reaming, the robotic arm 30provides haptic (force feedback) guidance to the surgeon. The hapticguidance constrains the surgeon's ability to manually move the surgicaltool to ensure that the actual bone cuts correspond in shape andlocation to planned bone cuts (i.e., cuts consistent with the surgicalplan).

In step S9 of FIG. 5B, the surgeon verifies that the registration (i.e.,the geometric relationship) between the acetabular tracking array andthe pelvis 12 is still valid by contacting the pelvis checkpoint with atracked probe as described, for example, in U.S. patent application Ser.No. 11/750,807 (Pub. No. US 2008/0004633), filed May 18, 2007, andhereby incorporated by reference herein in its entirety. If registrationhas degraded (e.g., because the acetabular tracking array was bumpedduring reaming), the pelvis 12 is re-registered. Registrationverification can be performed any time the surgeon wants to check theintegrity of the acetabular registration.

In step S10 of FIG. 5B, the prosthetic component 316 is implanted on thereamed acetabulum 22 using an impactor tool. In a manner identical tothat described above in connection with step S8 (reaming), during theimpaction step S10, the display device 9 can show the planned pose 500,the activation region 510, the representations 512, 514 of the anatomy,and a representation of the surgical tool. Also as described above inconnection with step S8, if the surgeon moves the end effector 40 tooverride the haptic feedback, the controller can initiate automaticcontrol of the surgical tool to substantially align at least one aspectof the actual pose with the corresponding desired aspect of the targetpose.

E. Leg Length Calculation

In step S11 of FIG. 5B, the surgeon installs the femoral component onthe femur 14. Next, in step S12 of FIG. 5B and step T11 of FIG. 8, thesurgeon determines leg length and femoral offset. At any time during thesurgical procedure, the display device 9 can show data related toprogress and/or outcome. For example, after reaming in step S8 and/orimpacting in step S10), data relating to the actual position of thereamed acetabulum 22 (or the implanted acetabular cup) can include, forexample, numerical data representing error between the actual andplanned locations in the three orthogonal planes of the patient'sanatomy (i.e., medial/lateral, superior/inferior, andanterior/posterior).

In certain instances, step S12 of FIG. 5B and step T11 of FIG. 8 fordetermining leg length discrepancy (LLD) may include comparing thepre-operatively determined LLD with an intra-operative measurement ofLLD.

In certain instances, intra-operative LLD may be determined by based onthe position of the femoral and pelvic tracking arrays 634, 632, as seenin FIGS. 12A and 12B. FIG. 12A depicts a coronal view of a patient'sskeletal structure including the pelvis 12, femur 14, and knee joint 10with a pelvic tracking array 634 positioned in the pelvis 12 and afemoral tracking array 632 positioned in the femur 14 prior to theresection of the proximal femur including the femoral neck and head 18,16. FIG. 12B depicts a coronal view of a patient's skeletal structureincluding the pelvis 12, femur 14, and knee joint 10 with a pelvictracking array 634 positioned in the pelvis 12 and a femoral trackingarray 632 positioned in the femur 14 following the resection of theproximal femur and implantation of femoral and acetabular components ofa hip implant system 636.

Upon registering the pelvis 12 and the femur 14 via the pelvic trackingarray 634 and the femoral tracking array 632, the system 5 may calculatea first value or distance D10 between the tracking arrays 634, 632 in agiven pose(s) (i.e., position and orientation) of the femur 14 relativeto the pelvis 12. For example, the surgeon may position the patient'sfemur 14 such that the femoral mechanical axis (not shown in FIG. 12A)is parallel to the vertical axis (not shown in FIG. 12A). In certaininstances, the surgeon may use the tracking ability of the system 5 toverify that the femur 14 is positioned in the correct pose relative tothe pelvis 12 for determining the distance D20.

Following the hip replacement procedure where the proximal femur isresected and replaced with a femoral component that is positioned withinan acetabular component, as seen in FIG. 12B, the surgeon may calculatea second value or distance D20 between the tracking arrays 634, 632 in agiven pose(s) of the femur 14 relative to the pelvis 12. In certaininstances, the pose may be the same for determining the distances D10,D20.

The difference between the pre-resection distance D10 and thepost-resection distance D20 is given by distance D30, as seen in FIG.12B. The distance D30 represents the change in leg length that resultedfrom the actual hip replacement procedure. This distance D30 may then becompared with the pre-operatively calculated LLD. In certain instances,where a hip replacement procedure was the only planned procedure (i.e.,a knee arthroplasty was not planned for), the post-operative distanceD30 may be compared with the pre-operative value of LLD. If, forexample, a surgeon desired to correct a knee deformity thatpre-operatively showed a 3 mm shorter leg, a post-operative distance D30change of 3 mm longer, for example, may indicate that the hipreplacement procedure was successful in correcting LLD.

In certain instances, where a knee arthroplasty procedure is to takeplace at a given time after the hip replacement procedure, the distanceD30 associated with a change in the proximal femur may be one componentof the overall LLD to be fixed. That is, the surgeon may calculate ordetermine that the hip replacement procedure will fix total LLD by afactor of X, and a subsequent knee replacement procedure (e.g., to fixvarus/valgus deformity) will fix total LLD by a factor of Y, where Xplus Y equals the total LLD.

In certain instances, a pre- and post-resection determination of leglength may be determined without the aid of a femoral tracking array.For example, as seen in FIG. 12C, which is a front view of a right sideof a pelvis 12, hip joint 10, femur 14, knee joint 17, patella 19,fibula 21, and talus 604 prior to a hip replacement surgery, a surgeonmay calculate a pre-resection LLD as a distance D40 between the pelvictracking array 634 and a distal landmark such as a distal aspect of thetalus 638 or a distal aspect of the tibia 640. As seen in FIG. 12D,which is a front view of a right side of a pelvis 12, hip joint 10,femur 14, knee joint 17, patella 19, fibula 21, and talus 604 followinga hip replacement surgery, the surgeon may calculate a post-resectionLLD as a distance D50 between the pelvic tracking array 634 and a distallandmark such as a distal aspect of the talus 638 or a distal aspect ofthe tibia 640.

The difference between the pre-resection distance D40 and thepost-resection distance D50 is given by distance D60, as seen in FIG.12D. The distance D60 represents the change in leg length that resultedfrom the actual hip replacement procedure. This distance D60 may then becompared with the pre-operatively calculated LLD. In certain instances,where a hip replacement procedure was the only planned procedure (i.e.,a knee arthroplasty was not planned for), the post-operative distanceD60 may be compared with the pre-operative value of LLD. If, forexample, a surgeon desired to correct a knee deformity thatpre-operatively showed a 3 mm shorter leg, a post-operative distance D60change of 3 mm longer, for example, may indicate that the hipreplacement procedure was successful in correcting LLD.

In certain instances, where a knee arthroplasty procedure is to takeplace at a given time after the hip replacement procedure, the distanceD60 associated with a change in the proximal femur may be one componentof the overall LLD to be fixed. That is, the surgeon may calculate ordetermine that the hip replacement procedure will fix total LLD by afactor of X, and a subsequent knee replacement procedure (e.g., to fixvarus/valgus deformity) will fix total LLD by a factor of Y, where Xplus Y equals the total LLD.

Instead of using the femoral tracking array (shown in FIGS. 12A-12B) thedistal landmarks may be captured by the surgeon via a digitizer ortracked navigation probe. For example, the surgeon may place the distaltip of a tracked probe against a distal landmark (e.g., distal aspect oftibia 640 or talus 638) and the location of the landmark may be storedby the system 5. In this way, the surgeon may capture or log thelocation of the distal landmark on the patient's distal extremity pre-and post-hip replacement, and the difference in the distance between thedistal extremity and the pelvic tracking array 634 may provide adifference in LLD as a result of the surgical procedure. It is notedthat the distal aspects of the tibia and talus 640, 638 are exemplaryand other distal landmarks may be similarly employed without departingfrom the scope of the present disclosure.

V. Example Computing System

Referring to FIG. 13, a detailed description of an example computingsystem 1300 having one or more computing units that may implementvarious systems and methods discussed herein is provided. The computingsystem 1300 may be applicable to any of the computers or systemsutilized in the preoperative or intra-operative planning of thearthroplasty procedure (e.g., registration, leg length discrepancy), andother computing or network devices. It will be appreciated that specificimplementations of these devices may be of differing possible specificcomputing architectures not all of which are specifically discussedherein but will be understood by those of ordinary skill in the art.

The computer system 1300 may be a computing system that is capable ofexecuting a computer program product to execute a computer process. Dataand program files may be input to the computer system 1300, which readsthe files and executes the programs therein. Some of the elements of thecomputer system 1300 are shown in FIG. 13, including one or morehardware processors 1302, one or more data storage devices 1304, one ormore memory devices 1308, and/or one or more ports 1308-1310.Additionally, other elements that will be recognized by those skilled inthe art may be included in the computing system 1300 but are notexplicitly depicted in FIG. 13 or discussed further herein. Variouselements of the computer system 1300 may communicate with one another byway of one or more communication buses, point-to-point communicationpaths, or other communication means not explicitly depicted in FIG. 13.

The processor 1302 may include, for example, a central processing unit(CPU), a microprocessor, a microcontroller, a digital signal processor(DSP), and/or one or more internal levels of cache. There may be one ormore processors 1302, such that the processor 1302 comprises a singlecentral-processing unit, or a plurality of processing units capable ofexecuting instructions and performing operations in parallel with eachother, commonly referred to as a parallel processing environment.

The computer system 1300 may be a conventional computer, a distributedcomputer, or any other type of computer, such as one or more externalcomputers made available via a cloud computing architecture. Thepresently described technology is optionally implemented in softwarestored on the data stored device(s) 1304, stored on the memory device(s)1306, and/or communicated via one or more of the ports 1308-1310,thereby transforming the computer system 1300 in FIG. 13 to a specialpurpose machine for implementing the operations described herein.Examples of the computer system 1300 include personal computers,terminals, workstations, mobile phones, tablets, laptops, personalcomputers, multimedia consoles, gaming consoles, set top boxes, and thelike.

The one or more data storage devices 1304 may include any non-volatiledata storage device capable of storing data generated or employed withinthe computing system 1300, such as computer executable instructions forperforming a computer process, which may include instructions of bothapplication programs and an operating system (OS) that manages thevarious components of the computing system 1300. The data storagedevices 1304 may include, without limitation, magnetic disk drives,optical disk drives, solid state drives (SSDs), flash drives, and thelike. The data storage devices 1304 may include removable data storagemedia, non-removable data storage media, and/or external storage devicesmade available via a wired or wireless network architecture with suchcomputer program products, including one or more database managementproducts, web server products, application server products, and/or otheradditional software components. Examples of removable data storage mediainclude Compact Disc Read-Only Memory (CD-ROM), Digital Versatile DiscRead-Only Memory (DVD-ROM), magneto-optical disks, flash drives, and thelike. Examples of non-removable data storage media include internalmagnetic hard disks, SSDs, and the like. The one or more memory devices1306 may include volatile memory (e.g., dynamic random access memory(DRAM), static random access memory (SRAM), etc.) and/or non-volatilememory (e.g., read-only memory (ROM), flash memory, etc.).

Computer program products containing mechanisms to effectuate thesystems and methods in accordance with the presently describedtechnology may reside in the data storage devices 1304 and/or the memorydevices 1306, which may be referred to as machine-readable media. Itwill be appreciated that machine-readable media may include any tangiblenon-transitory medium that is capable of storing or encodinginstructions to perform any one or more of the operations of the presentdisclosure for execution by a machine or that is capable of storing orencoding data structures and/or modules utilized by or associated withsuch instructions. Machine-readable media may include a single medium ormultiple media (e.g., a centralized or distributed database, and/orassociated caches and servers) that store the one or more executableinstructions or data structures.

In some implementations, the computer system 1300 includes one or moreports, such as an input/output (I/O) port 1308 and a communication port1310, for communicating with other computing, network, or vehicledevices. It will be appreciated that the ports 1308-1310 may be combinedor separate and that more or fewer ports may be included in the computersystem 1300.

The I/O port 1308 may be connected to an I/O device, or other device, bywhich information is input to or output from the computing system 1300.Such I/O devices may include, without limitation, one or more inputdevices, output devices, and/or environment transducer devices.

In one implementation, the input devices convert a human-generatedsignal, such as, human voice, physical movement, physical touch orpressure, and/or the like, into electrical signals as input data intothe computing system 1300 via the I/O port 1308. Similarly, the outputdevices may convert electrical signals received from computing system1300 via the I/O port 1308 into signals that may be sensed as output bya human, such as sound, light, and/or touch. The input device may be analphanumeric input device, including alphanumeric and other keys forcommunicating information and/or command selections to the processor1302 via the I/O port 1308. The input device may be another type of userinput device including, but not limited to: direction and selectioncontrol devices, such as a mouse, a trackball, cursor direction keys, ajoystick, and/or a wheel; one or more sensors, such as a camera, amicrophone, a positional sensor, an orientation sensor, a gravitationalsensor, an inertial sensor, and/or an accelerometer; and/or atouch-sensitive display screen (“touchscreen”). The output devices mayinclude, without limitation, a display, a touchscreen, a speaker, atactile and/or haptic output device, and/or the like. In someimplementations, the input device and the output device may be the samedevice, for example, in the case of a touchscreen.

In one implementation, a communication port 1310 is connected to anetwork by way of which the computer system 1300 may receive networkdata useful in executing the methods and systems set out herein as wellas transmitting information and network configuration changes determinedthereby. Stated differently, the communication port 1310 connects thecomputer system 1300 to one or more communication interface devicesconfigured to transmit and/or receive information between the computingsystem 1300 and other devices by way of one or more wired or wirelesscommunication networks or connections. Examples of such networks orconnections include, without limitation, Universal Serial Bus (USB),Ethernet, Wi-Fi, Bluetooth®, Near Field Communication (NFC), Long-TermEvolution (LTE), and so on. One or more such communication interfacedevices may be utilized via the communication port 1310 to communicateone or more other machines, either directly over a point-to-pointcommunication path, over a wide area network (WAN) (e.g., the Internet),over a local area network (LAN), over a cellular (e.g., third generation(3G) or fourth generation (4G)) network, or over another communicationmeans. Further, the communication port 1310 may communicate with anantenna or other link for electromagnetic signal transmission and/orreception.

In an example implementation, patient data, bone models (e.g., generic,patient specific), transformation software, tracking and navigationsoftware, registration software, and other software and other modulesand services may be embodied by instructions stored on the data storagedevices 1304 and/or the memory devices 1306 and executed by theprocessor 1302. The computer system 1300 may be integrated with orotherwise form part of the surgical system 100.

The system set forth in FIG. 13 is but one possible example of acomputer system that may employ or be configured in accordance withaspects of the present disclosure. It will be appreciated that othernon-transitory tangible computer-readable storage media storingcomputer-executable instructions for implementing the presentlydisclosed technology on a computing system may be utilized.

In the present disclosure, the methods disclosed herein, for example,those shown in FIGS. 5 and 8, among others, may be implemented as setsof instructions or software readable by a device. Further, it isunderstood that the specific order or hierarchy of steps in the methodsdisclosed are instances of example approaches. Based upon designpreferences, it is understood that the specific order or hierarchy ofsteps in the method can be rearranged while remaining within thedisclosed subject matter. The accompanying method claims presentelements of the various steps in a sample order, and are not necessarilymeant to be limited to the specific order or hierarchy presented.

The described disclosure including any of the methods described hereinmay be provided as a computer program product, or software, that mayinclude a non-transitory machine-readable medium having stored thereoninstructions, which may be used to program a computer system (or otherelectronic devices) to perform a process according to the presentdisclosure. A machine-readable medium includes any mechanism for storinginformation in a form (e.g., software, processing application) readableby a machine (e.g., a computer). The machine-readable medium mayinclude, but is not limited to, magnetic storage medium, optical storagemedium; magneto-optical storage medium, read only memory (ROM); randomaccess memory (RAM); erasable programmable memory (e.g., EPROM andEEPROM); flash memory; or other types of medium suitable for storingelectronic instructions.

While the present disclosure has been described with reference tovarious implementations, it will be understood that theseimplementations are illustrative and that the scope of the presentdisclosure is not limited to them. Many variations, modifications,additions, and improvements are possible. More generally, embodiments inaccordance with the present disclosure have been described in thecontext of particular implementations. Functionality may be separated orcombined in blocks differently in various embodiments of the disclosureor described with different terminology. These and other variations,modifications, additions, and improvements may fall within the scope ofthe disclosure as defined in the claims that follow.

In general, while the embodiments described herein have been describedwith reference to particular embodiments, modifications can be madethereto without departing from the spirit and scope of the disclosure.Note also that the term “including” as used herein is intended to beinclusive, i.e. “including but not limited to.”

The construction and arrangement of the systems and methods as shown inthe various exemplary embodiments are illustrative only. Although only afew embodiments have been described in detail in this disclosure, manymodifications are possible (e.g., variations in sizes, dimensions,structures, shapes and proportions of the various elements, values ofparameters, mounting arrangements, use of materials, colors,orientations, etc.). For example, the position of elements may bereversed or otherwise varied and the nature or number of discreteelements or positions may be altered or varied. Accordingly, all suchmodifications are intended to be included within the scope of thepresent disclosure. The order or sequence of any process or method stepsmay be varied or re-sequenced according to alternative embodiments.Other substitutions, modifications, changes, and omissions may be madein the design, operating conditions and arrangement of the exemplaryembodiments without departing from the scope of the present disclosure.

1. A computing device comprising a processing device and acomputer-readable medium with one or more executable instructions storedthereon, wherein the processing device of the computing device executesthe one or more instructions to perform the operations of: receivingpatient bone data associated with first and second sides of a patient;generating first and second pluralities of bone models from the patientbone data, the first plurality of bone models associated with the firstside of the patient and the second plurality of bone models associatedwith the second side of the patient, the first plurality of bone modelsincluding a first side pelvic model, a first side femur model, a firstside tibia model, and a first side foot model, the second plurality ofbone models including a second side pelvic model, a second side femurmodel, a second side tibia model, and a second side foot model;identifying anatomical landmarks in the patient bone data or the firstand second pluralities of bone models, the anatomical landmarkscomprising: a first side pelvic point, a first side femur point, a firstside foot point, a second side pelvic point, a second side femur point,and a second side foot point; orienting the first and second pluralitiesof bone models in a coordinate system such that: a pelvic axisassociated with the first side pelvic model and second side pelvic modelis generally perpendicular to a longitudinal axis of the first andsecond pluralities of bone models; and a first bone axis associated withthe first plurality of bone models and a second bone axis associatedwith second plurality of bone models are generally parallel to thelongitudinal axis; and calculating a leg length discrepancy between thefirst and second pluralities of bone models, respectively, afterorienting the first and second pluralities of bone models.
 2. The systemof claim 1, wherein the pelvic axis extends through the first sidepelvic point and the second side pelvic point.
 3. The system of claim 1,wherein the first side foot point is associated with a first talus bone,and the second side foot point is associated with a second talus bone.4. The system of claim 1, wherein the first bone axis comprises a firstmechanical axis, and the second bone axis comprises a second mechanicalaxis.
 5. The system of claim 4, wherein the first side femur point isassociated with a first femoral head center, and the second side femurpoint is associated with a second femoral head center, the firstmechanical axis is defined between the first side femur point and thefirst side foot point, and the second mechanical axis is defined betweenthe second side femur point and the second side foot point.
 6. Thesystem of claim 4, wherein the first mechanical axis is a full legmechanical axis of the first plurality of bone models, and the secondmechanical axis is a full leg mechanical axis of the second plurality ofbone models.
 7. The system of claim 4, wherein the anatomical landmarksfurther comprise: a first side knee center point, and a second side kneecenter point.
 8. The system of claim 7, wherein the first mechanicalaxis is defined between the first side femur point and the first sideknee center point, and the second mechanical axis is defined between thesecond side femur point and the second side knee center point.
 9. Thesystem of claim 7, wherein the operations further include: adjusting anangular condition at one or both of the first side knee center point andthe second side knee center point.
 10. The system of claim 9, whereinthe angular condition is a valgus or varus deformity.
 11. A computingdevice comprising a processing device and a computer-readable mediumwith one or more executable instructions stored thereon, wherein theprocessing device of the computing device executes the one or moreinstructions to perform the operations of: receiving patient bone dataassociated with first and second sides of a patient; generating firstand second pluralities of bone models from the patient bone data, thefirst plurality of bone models associated with the first side of thepatient and the second plurality of bone models associated with thesecond side of the patient, the first plurality of bone models includinga first side pelvic model, a first side femur model, a first side tibiamodel, and a first side foot model, the second plurality of bone modelsincluding a second side pelvic model, a second side femur model, asecond side tibia model, and a second side foot model; identifyinganatomical landmarks in the patient bone data or the first and secondpluralities of bone models, the anatomical landmarks comprising: a firstside pelvic point, a first side femur point, a first side foot point, asecond side pelvic point, a second side femur point, and a second sidefoot point; arranging the first and second pluralities of bone models ina coordinate system such that: a first axis associated with the firstside pelvic model and second side pelvic model is generallyperpendicular to a second axis extending in a distal-proximal direction;a first bone axis associated with the first plurality of bone models isin a first angular orientation relative to the second axis; and a secondbone axis associated with second plurality of bone models is in a secondangular orientation relative to the second axis; and calculating a leglength discrepancy between the first and second pluralities of bonemodels, respectively, after arranging the first and second pluralitiesof bone models.
 12. The system of claim 11, wherein the first axis is apelvic axis that extends through the first side pelvic point and thesecond side pelvic point.
 13. The system of claim 11, wherein the firstangular orientation is a parallel orientation, and the second angularorientation is a parallel orientation.
 14. The system of claim 11,wherein the first bone axis comprises a first mechanical axis, and thesecond bone axis comprises a second mechanical axis.
 15. The system ofclaim 14, wherein the first side femur point is associated with a firstfemoral head center, and the second side femur point is associated witha second femoral head center, the first mechanical axis is definedbetween the first side femur point and the first side foot point, andthe second mechanical axis is defined between the second side femurpoint and the second side foot point.
 16. The system of claim 14,wherein the first mechanical axis is a full leg mechanical axis of thefirst plurality of bone models, and the second mechanical axis is a fullleg mechanical axis of the second plurality of bone models.
 17. Thesystem of claim 14, wherein the anatomical landmarks further comprise: afirst side knee center point, and a second side knee center point. 18.The system of claim 17, wherein the first mechanical axis is definedbetween the first side femur point and the first side knee center point,and the second mechanical axis is defined between the second side femurpoint and the second side knee center point.
 19. The system of claim 17,wherein the operations further include: adjusting an angular conditionat one or both of the first side knee center point and the second sideknee center point.
 20. The system of claim 19, wherein the angularcondition is a valgus or varus deformity.